UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046467 |
|---|---|
| Receipt number | R000053017 |
| Scientific Title | Examination of changes in muscle quality in patients with acute stroke patients and factors that influence the changes |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2025/07/08 12:43:26 |
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Basic information
Public title
Changes in muscle quality in patients with acute stroke patients and assessment of factors that influence the changes
Acronym
Relationship between stroke and muscle quality
Scientific Title
Examination of changes in muscle quality in patients with acute stroke patients and factors that influence the changes
Scientific Title:Acronym
Relationship between stroke and muscle quality
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The change in muscle quality in the acute elderly stroke patients has been evaluated by the Phase Angle (PA) that can be measured by a body composition analyzer using the BIA method, and the factors that influence the change in PA are analyzed.
Basic objectives2
Others
Basic objectives -Others
It has become clear that measurement of muscle quality by a body composition analyzer using the bioelectrical impedance method is effective. According to the applicant's examination so far, the muscle quality of elderly stroke patients was significantly lower than that of healthy subjects during the recovery period, and the value had a strong influence on ADL recovery. It was thought that if the deterioration of muscle quality in the acute phase could be prevented, the recovery of ADL in the convalescent phase could be promoted more smoothly. In this study, we will clarify the preventive method for muscle deterioration in the acute phase of stroke by analyzing the changes in muscle quality in the acute phase of elderly stroke patients and the factors that influence the deterioration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Stroke Severity (NIHSS), Dietary Content, Energy Intake, Amount of protein intake, Skeletal muscle mass, PA value, TP, Alb, mass of masseter muscle
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients who were admitted to the stroke care unit and received rehabilitation treatment.
Key exclusion criteria
Patients with a pacemaker
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotuga, Tochigi
TEL
+81282872170
irisawah@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880, Kitakobayashi, Mibu, Shimotsuga
TEL
+81282872170
Homepage URL
irisawah@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Clinical Research Management Center
Address
880, Kitakobayasshi, Mibu, Shimotsuga, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
獨協医科大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1548796/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1548796/full
Number of participants that the trial has enrolled
166
Results
Muscle mass and quality significantly decreased in both men and women1 week after admission. Rehabilitation intervention time significantly reduced the loss of muscle mass. However, stroke severity did not affect variations in body composition.
Results date posted
| 2025 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted this prospective study at a stroke care unit (SCU) at Dokkyo Medical University Hospital in Japan, in accordance with the Declaration of Helsinki, between January and December 2022.
Participant flow
A total of 198 patients with stroke participated in this trial. However, patients with pacemakers and severe cognitive impairment who were discharged early were excluded (Figure 1). Therefore, 166 patients (58 women and 108 men) were included in this study.
Adverse events
None
Outcome measures
Body composition assessment was performed on patients admitted to the stroke care unit at the time of admission and 1 week later. Additionally, associations between rehabilitation intervention time, nutritional dosage and administration method, and stroke severity were examined to which factors were affecting body composition.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Main results published
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053017
